K914015 is an FDA 510(k) clearance for the CLEMENT-PILLING CHOLANGIOGRAPHY CATH GUIDE/CLAMP, a Catheter, Cholangiography (Class I — General Controls, product code GBZ), submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on November 21, 1991, 73 days after receiving the submission on September 9, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K914015 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 1991 |
| Decision Date | November 21, 1991 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBZ — Catheter, Cholangiography |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |